A Safety Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor

• Status: Recruiting
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study will assess the pharmacokinetics and pharmacodynamics of STSP-0601 at five dose levels. The results will help identify the most optimal doses to treat bleedings in hemophilia patients with inhibitors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd

Criteria

Inclusion Criteria:

• 18 years old ≤age≤65 years of age,male.

• Hemophilia A or B patients with inhibitors.

• Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.

• Establish proper venous access.

• Provide signed informed consent.

Exclusion Criteria:

• Have any coagulation disorder other than hemophilia A or B.

• Treat with prophylactic treatment of coagulation factor.

• Treat with anticoagulant within 7d of the time of study drug administration.

• Have an active, ongoing bleeding for which the patient is being treated, or treatment for a bleeding was stopped within 7d of the time of study drug administration.

• Have a history of arterial and/or venous thromboembolic events.

• Have platelet count <100,000/mL.

• Severe liver or kidney disease.

• Accept major operation or blood transfusion within 1 month of the time of screening.

• HIV antibody positive.

• Have a known allergy to Blood product.

• Participate in other clinical research within 1 month of the time of study drug administration.